Official recall record
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intende
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-08-18
- Country of alert
- Denmark
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05700693930923
- Brand on record
- Radiometer Medical ApS
What the authority reported
In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-11-12.
Record last checked against the registry on 2026-11-12.
Other recalls from this brand
- 2024-05-31 · US FDA — Medical Devices
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro tes
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